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NCT Number: NCT03439371

Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.

Recruiting

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Estaing, Clermont-Ferrand, France

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About this study

Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient affiliated to a social security regimen or beneficiary of the same
  • Signed written informed consent form
  • Patient, ≥ 60 years-old - < 75 years-old, with established diagnosis of de novo or secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with established myelodysplasic syndromes (RAEB), in pathologically confirmed complete remission following anti-leukemic induction therapy (<5% blasts)
  • Contra-indication to conditioning regimen in conventional allogeneic transplantation

Exclusion criteria

  • Patient with established diagnosis of acute myeloid leukemia with standard-risk cytogenetic profile
  • Promyelocytic leukemia t(15;17)
  • CBF-AML t(8;21) or inv(16)
  • Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3- and double mutation CEBPα or chronic myeloid leukemia in blastic phase
  • Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
  • Refusing participation

Treatment and study plan

HLA-mismatched micro-transplantation after induction chemotherapy

Other

HLA-mismatched micro-transplantation after induction chemotherapy

Primary outcomes

  1. Rate of overall survival

    Time frame: 2 years

    Rate of overall survival will be reported.

Secondary outcomes

  1. Hematopoietic recovery

    Time frame: 3 months

    Number of platelets will be reported.

  2. Hematopoietic recovery

    Time frame: 3 months

    Number of neutrophils will be reported.

  3. Hematopoietic recovery

    Time frame: 3 months

    Percentage of leukaemic blasts will be reported.

  4. Rate of complete remission

    Time frame: 2 years

    Rate of complete remission :

  5. GVHD (graft versus host disease)

    Time frame: 2 years

    Presence of graft versus host disease will be reported.

  6. Median overall survival

    Time frame: 2 years

    Median overall survival will be calculated.

  7. Median progression-free survival

    Time frame: 2 years

    Median progression-free survival will be calculated.

  8. Microchimerism

    Time frame: 3 months

    Presence of microchimerism will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Daguenet, PhD

CONTACT

[email protected]

04 77 91 70 89 ext. +33

Jérôme Cornillon, MD

CONTACT

[email protected]

04 77 91 67 26 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Institut de Cancérologie de la Loire

Registry information

Official study title

A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)

Acronym: MTSA

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Feb 20, 2018
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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